Devices and methods for the removal of lenticular tissue

ABSTRACT

An exemplary surgical device includes a shaft with a lumen defined therethrough and an element movable from a stored position to a deployed position in which a larger portion of the element extends out of the distal end of the lumen; wherein motion from the stored position to the deployed position causes a first leg of the element to advance distally relative to the distal end of the shaft, and causes a second leg of the element to move proximally relative to the distal end of the shaft.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. application Ser.No. 16/564,551 filed Sep. 9, 2019, which is a continuation of U.S.application Ser. No. 15/688,024, filed Aug. 28, 2017, issued as U.S.Pat. No. 10,463,535 entitled DEVICES AND METHODS FOR THE REMOVAL OFLENTICULAR TISSUE, which is a continuation of U.S. application Ser. No.14/857,518, filed Sep. 17, 2015, issued as U.S. Pat. No. 9,775,743,entitled DEVICES AND METHODS FOR THE REMOVAL OF LENTICULAR TISSUE, whichclaims priority from U.S. Provisional Ser. No. 62/051,396, filed on Sep.17, 2014, entitled METHOD AND DEVICE FOR LENS FRAGMENTATION USINGFILAMENT CUTTING IN CATARACT SURGERY, and U.S. Provisional Ser. No.62/099,590, filed on Jan. 5, 2015, entitled METHOD AND DEVICE FORAB-INTERNO INTERVENTIONAL ENDOCAPSULAR FRAGMENTATION, RETRIEVAL ANDEXTRACTION IN OPHTHALMIC SURGERY, which are hereby incorporated byreference in their entirety for all purposes.

FIELD OF THE INVENTION

This invention relates generally to surgical devices, and morespecifically to the extraction of lenticular or other tissue inophthalmic surgery.

BACKGROUND OF THE INVENTION

Certain types of conventional ophthalmic surgery require breaking uplenticular tissue and solid intraocular objects, such as the intraocularlens, into pieces so that the tissue can be extracted from the eye.Extraction of lenses for cataract surgery is one of the most commonoutpatient surgical fields with more than 3 million cases performedannually in the United States alone. The lens resides within ananatomical structure referred to as the capsular bag, which separatesthe vitreous cavity from the anterior chamber (located between thecapsular bag and the cornea). It is undesirable to allow fluidcommunication between the vitreous cavity and the anterior chamber, soduring the process of extraction of the lens, care is taken to maintainthe integrity of the posterior surface of the capsular bag. However, thecapsular bag is composed of thin, delicate tissue. As a result, thephysician must exercise extreme care in removing lens tissue to avoidunintended damage to the capsular bag. Further complicating theprocedure, the lens is typically removed from the anterior surface ofthe capsular bag through a generally circular incision. The procedure,and the incision resulting from the procedure, is referred to as acapsulorhexis. Typically, the capsulorhexis does not exceed 2.8-3 mm indiameter. Generally, cataract surgery and other surgical procedures thattreat the lens are performed by making a small incision in the edge ofthe cornea, providing access to the anterior chamber and to the anteriorsurface of the capsular bag. Afterward, capsulorhexis is performed, andthen that opening is able to be utilized for surgical access to thelens.

During cataract surgery a commonly used method for lens extraction isphacoemulsification, which uses ultrasonic energy to break up the lens,after which the lens fragments are aspirated. Other methods of lensfragmentation and extraction have include the use of mechanicalinstruments, such as hooks or knives, or energy-delivery instruments,such as a laser, to break up the lens into fragments and then extractthrough an incision in the cornea in an ab-interno approach.

However, existing tools and techniques do not ensure full-thicknessfragmentation of the lens. These techniques approach the lens from theanterior surface of the eye, and therefore the dissection forces exertedby mechanical instruments are limited such that they are ofteninsufficient to accomplish a full-thickness segmentation. Further, dueto the surgical approach through the incision at the edge of the cornea,a mechanical instrument is delivered at an angle substantially parallelto the plane defined by the capsulorhexis. As a result, a conventionalsurgical snare, loop or wire retrieval tool is not in an orientation inwhich that device could be looped around the lens to provide forfragmentation or extraction. Further, even if such a conventional toolcould be looped around the lens, which it cannot, the wire of the snarewould run the risk of applying excessive, damaging force to the capsularbag as it would be moved into position. Energy-delivery instruments arelimited in their ability to cut sections of the lens which arephysically close to other delicate anatomical structures such as thecapsular bag. For instance, a laser is generally not used to cut theposterior edge of the lens because it is in close proximity to theposterior edge of the capsular bag, leaving a lens that is not fullyfragmented and must be fragmented carefully using secondary techniques.

For these reasons, phacoemulsification has become the most popularmethod of lens removal. However, phacoemulsification has its owndrawbacks. As fluid and substances are aspirated from the capsular bagand the anterior chamber, other fluids such as saline are inspirated tomaintain a constant volume or pressure. The flow of the fluids in theeye during inspiration and aspiration may create turbulent flow whichmay have a deleterious effect on the tissue within the eye, such as thecorneal endothelium. The ultrasonic energy used in phacoemulsificationcan have its own negative consequences on ocular tissue. Further,phacoemulsification requires expensive and bulky capital equipment,limiting the locations in which phacoemulsification can be performed.

BRIEF SUMMARY OF THE INVENTION

The present disclosure recognizes that existing techniques for removinglenticular tissue are generally cumbersome and inefficient. Further, inorder to overcome the risks of damaging the capsular bag with existingtechniques, the lens is not completely broken up or dissolved, leavingone or more fragments sized larger than clinically desirable.

Therefore, the present disclosure provides for devices and methods thateffectively break up the lens into small fragments and capture thosefragments. Such devices and methods optionally complement or replaceother devices or methods for eye surgery. Such methods and interfacesreduce the risk of damage to ocular tissue, such as the capsular bag,and produce a more efficient surgical experience.

In some embodiments, a surgical device includes a shaft with a lumendefined therethrough; and an element movable from a stored position to adeployed position in which a larger portion of the element extends outof the distal end of the lumen; wherein motion from the stored positionto the deployed position causes a first leg of the element to advancedistally relative to the distal end of the shaft, and causes a secondleg of the element to move proximally relative to the distal end of theshaft.

In some embodiments, a device for surgery on a human eye (which includesa capsular bag, a lens inside the capsular bag, and a cornea) includes atube with a lumen defined therethrough; and a sectioning elementconfigured to change between at least a first shape and a second shape,the second shape having a perimeter, and the sectioning elementextending from the distal end of the lumen; wherein the first shape issized to insert through a capsulorhexis on the anterior surface of thecapsular bag, the diameter of is the capsulorhexis less than thediameter of the lens; wherein the sectioning element is movable from thefirst shape to the second shape to move between the lens and thecapsular bag, such that when the sectioning element has the secondshape, the sectioning element includes at least a portion of the lenswithin its perimeter; and wherein the sectioning element is movable to athird shape from the second shape to apply cutting force to the lens.

In some embodiments, a device for eye surgery includes a shaft with alumen defined therethrough; an inner rotating element positioned atleast partially in the lumen; an outer rotating element positioned atleast partially in the lumen, and positioned radially between the innerrotating element and the shaft a first plurality of straps extendingdistally from the distal end of the outer rotating element, each of thefirst plurality of straps circumferentially spaced from one another; asecond plurality of straps extending distally from the distal end of theinner rotating element, each of the second plurality of strapscircumferentially spaced from one another; and a tip connected to thedistal end of each of the straps; wherein the first plurality of strapsand second plurality of straps are movable from a closed position to anopen position; and wherein at least one of the first plurality of strapsand second plurality of straps is rotatable relative to the other in theopen position.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side schematic view of the ocular anatomy, showing theinsertion of a shaft and sectioning element through an incision in theside of the cornea.

FIG. 2 is a top view of the sectioning element in a deployed position.

FIG. 3 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a first, insertionconfiguration.

FIG. 4 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a second, captureconfiguration.

FIG. 5 is a perspective view of the capsular bag, with a completedcapsulorhexis, with a sectioning element in a third, fragmentationposition.

FIG. 6 is a perspective view of the lens of FIG. 5, with the sectioningelement not shown for clarity.

FIG. 7 is a perspective view of the lens of FIG. 5, with the sectioningelement and capsular bag not shown for clarity.

FIG. 8 is perspective view of a surgical device including a handle,shaft and multiple sectioning elements.

FIG. 9 is a perspective view of the surgical device of FIG. 8, with thesectioning elements in the first, insertion configuration.

FIG. 10 is a perspective view of the surgical device of FIG. 8, with aleft slider advanced to expand a left sectioning element toward thesecond, capture configuration.

FIG. 11 is a perspective view of the surgical device of FIG. 8, with aleft slider fully advanced to expand the left sectioning element to thesecond, capture configuration.

FIG. 12 is a perspective view of the surgical device of FIG. 8, with aright slider advanced to expand a right sectioning element toward thesecond, capture configuration.

FIG. 13 is a perspective view of the surgical device of FIG. 8, with aright slider fully advanced to expand the right sectioning element tothe second, capture configuration.

FIG. 14 is a perspective view of FIG. 13, showing the sectioningelements relative to the lens.

FIG. 15 is a detail perspective view of the distal end of the surgicaldevice of FIG. 8.

FIG. 16 is a cutaway perspective view of the handle, with the rightslider in its initial position.

FIG. 17 is a detail perspective view of part of the handle of FIG. 16.

FIG. 18 is a detail perspective view of a different part of the handleof FIG. 16.

FIG. 19 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider partially advanced.

FIG. 20 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider advanced further distally than its position in FIG. 19.

FIG. 21 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider returned toward its original position.

FIG. 22 is a detail perspective view of the handle of FIGS. 16-18, withthe right slider returned to its original position.

FIG. 23 is a side view of another embodiment of two sectioning elementsextending from a shaft to encircle a lens.

FIG. 24 is a top view of another embodiment of two sectioning elementsextending from a shaft to encircle a lens, and a retention bag.

FIG. 25 is a perspective view of the distal end of another embodiment ofa surgical instrument in a first, insertion configuration.

FIG. 26 is a perspective view of the distal end of the surgicalinstrument of FIG. 25, in a second, expanded configuration.

FIG. 27 is a perspective view of the distal end of the surgicalinstrument of FIG. 25, in a second, expanded configuration, encircling alens fragment.

FIG. 28 is a perspective view of the distal end of the surgicalinstrument of FIG. 25, in a third, cage configuration.

FIG. 29 is a perspective view of the distal end of the surgicalinstrument of FIG. 25, in a fourth, removal configuration.

FIG. 30 is a side view of an alternate embodiment of a surgicalinstrument.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, the normal anatomy of the eye 1 includes a cornea2, capsular bag 6, and a lens 8 within the capsular bag 6. An incision 4is made in the edge of the cornea 2, and the surgeon performs acapsulorhexis procedure on the capsular bag 6, resulting in acapsulorhexis 10 in the anterior surface of the capsular bag 6. Thecapsulorhexis 10 may be performed in any suitable manner, such asincising with a scalpel, applying energy with a femtosecond laser orother energy-based cutter, incising under robotic or automated control,or in any other suitable manner. The capsulorhexis 10 can be torn or cutin a diameter of approximately 2.0 mm to 8.0 mm. According to otherembodiments, the capsulorhexis 10 may be made smaller in diameter than2.0 mm, particularly where fragments of the lens 8 (as described ingreater detail below) are small enough in size to be extracted through asmaller-diameter capsulorhexis 10. The capsulorhexis 10 can be made witha separate set of instruments such as micro-forceps, as is commonlydone. Alternatively, features and tools can be incorporated into thesurgical device 40 described herein to facilitate or completely performthe capsulorhexis. For example, micro-forceps could be added to thedistal end of the shaft 12 such that the tool 40 can perform thecapsulorhexis. As other examples, one or more of a blade, keratome,hook, laser, ablative energy applicator, or the like can be incorporatedinto or associated with the distal end of the shaft 12 for use duringsurgery. For example, an extending tip may be attached to the shaft 12,and used to rotate the lens 8 between fragmentation steps as describedherein. The extending tip may be a sharp tip which can be pierced intothe lens 8 such that the user can rotate the lens 8 to a new orientationand section the lens 8 from a different angle. According to someembodiments, any separate tools used by the surgeon to perform thecapsulorhexis are removed out of the incision 4 in the cornea 2.Referring also to FIG. 3, a shaft 12 is then inserted through theincision 3 in the cornea 2. As seen in FIG. 3, the distal end of theshaft 12 is positioned above (i.e., anterior to) the capsulorhexis 10,spaced apart from the capsulorhexis 10 but positioned within thecircumference of the capsulorhexis 10 as viewed from outside the eye 1.As seen in FIG. 1, the shaft 12 is generally parallel to the planedefined by the edges of the capsulorhexis 10 upon its insertion throughthe incision 3 in the cornea 2. In some embodiments, the distal end of asectioning element 16 extends out of the distal end of the shaft 12 in afirst, insertion configuration. In such embodiments, the tight radiusbend 24 may be positioned outside the shaft 12, already bent at leastpartially toward the proximal direction. In this way, even inembodiments where the sectioning element 16 is fabricated fromsuperelastic material, the angle through which the second leg 20 of thesectioning element 16 is bent during transition from the first,insertion configuration to the second, capture configuration is reduced.Further, less space is required within the lumen 14 of the shaft 12 tohold part of the sectioning element 16 than to hold all of it, allowingthe shaft 12 to be made smaller in diameter. The shaft 12 includes alumen 14 defined therethrough. According to some embodiments, the shaft12 is an ovular cross-section tube with a rounded tip. The ovularcross-section enhances the ability of the shaft 12 to be inserted intothe eye 1 through the corneal incision 4. Additionally, in the eventthat there are multiple sectioning elements, they may be arrangedside-by-side more easily in the lumen 14 of an ovular cross-sectionshaft 12. Alternately, the shaft 12 may have a circular cross-section ora cross-section of any other suitable shape. The proximal end of thesectioning element 16 extends through the lumen 14 of the shaft 12.Alternately, the entirety of the sectioning element 16 is positionedwithin the lumen 14 of the shaft 12 in the first, insertionconfiguration. Alternately, more than one sectioning element 16 isutilized, where each sectioning element 16 is initially in the first,insertion configuration. While a single sectioning element 16 isdescribed with regard to this particular embodiment for clarity, it willbe apparent in light of the further disclosure below that any suitablenumber of sectioning elements 16 may be provided and used in a singlelens removal procedure, and that the devices and methods herein are notlimited to the use of any particular number of sectioning elements 16.

According to some embodiments, the sectioning element 16 includes afirst end 18 and second end 20. As described in greater detail belowwith regard to FIGS. 16-22, one of the ends 18, 20 of the sectioningelement 16 may be movable relative to the shaft 12, while the other ofthe ends 18, 20 of the sectioning element 16 may be fixed relative tothe shaft 12. For example, the second end 20 of the sectioning element16 may be fixed relative to the shaft 12 and the first end 18 of thesectioning element 16 may be slidable relative to the shaft 12. Thesecond end 20 may be connected to the shaft 12 or to other structure bycrimping, welding, adhesives, mechanical interlocks, or any othersuitable structure or method. In some embodiments, the sectioningelement 16 is a wire with a circular, oval or other atraumaticcross-section. In other embodiments, the sectioning element 16 is astrap. As used in this document, a strap is a structure that is widerthan it is thick, as viewed longitudinally.

In the first, insertion configuration, where the distal end of thesectioning element 16 extends distally out of the shaft 12, thesectioning element 16 is sized and shaped to pass through a standardcorneal incision 4 without damaging the eye 1. The corneal incision 4 isgenerally 3.5 mm or less in width and made with a small knife. Thus, theouter diameter of the shaft 12 advantageously is 3.5 mm or less. Where adifferently-sized incision 4 is used, a different outer diameter ofshaft 12 may be used, keeping in mind that it is most desirable to formthe incision 4 as a line 5 mm or less in length. In other embodiments,the sectioning element 16 is positioned completely within the lumen 14of the shaft 12 such that it is within the inner diameter of the shaft12 as the shaft 12 is inserted through the incision 4, and is thenextended out of the shaft 12 once in the eye. Alternatively, additionalcomponents may be used to sheath the sectioning element 16 duringinsertion through the corneal incision. 4. For example, a tapered piecemay be positioned on the distal end of the shaft 12 which graduallytapers from the end of the shaft 12 down to a smaller cross section suchthat it can aid insertion through the corneal incision 4. The taperedpiece can also cover the sectioning element 16 to constrain it duringinsertion. The tapered piece can further have a slit in the front whichthe sectioning element 16 can extend through or tear open once it haspassed through the incision 4.

According to some embodiments, the sectioning element 16 is fabricatedfrom of a flexible or superelastic material, such as nickel-titaniumalloy, which allows the sectioning element 16 to bend and flex as it isinserted into the eye 1 through the corneal incision 4. In theseembodiments, the constricted shape of the sectioning element 16 may belarger in one or more dimensions than the corneal incision 4, and flexesto pass through the incision 4 as the shaft 12 moves toward thecapsulorhexis 10. Alternatively, the sectioning element 16 may not havea first, insertion configuration, and may be inserted through theincision 4 in the same configuration that is later utilized to engagethe lens 8. In such embodiments, the sectioning element 16 compresses asit passes through the corneal incision 4 and then re-expands once itenters the eye 1. In still other embodiments, the sectioning element 16may not have a first, insertion configuration, and may be insertedthrough the incision 4 in a larger configuration than is later utilizedto engage the lens 8. In still other embodiments, the sectioning element16 may be hooked, rotated, or otherwise inserted through the cornealincision 4 in any number of methods.

Referring to FIG. 4, the sectioning element 16 or elements are pusheddistally relative to the lumen 14 of the shaft 12. As set forth above,one leg 20 of the sectioning element 16 may be fixed, such that theother leg 18 of the section element 16 is pushed distally relative tothe lumen 14 of the shaft 12. As a result, the sectioning element movesfrom a first, insertion configuration to a second, captureconfiguration.

The sectioning element 16 may be fabricated from any suitable material.For example, as discussed above, shape memory materials such asnickel-titanium alloy may be used to allow the sectioning element 16 tomove to its predefined shape in the second, capture configuration, witha high amount of elasticity. In one embodiment, the nickel-titaniumalloy may be used in its superelastic condition, where thenickel-titanium alloy transforms its crystal structure to move from thefirst, insertion configuration to the second, capture configuration. Inother embodiments, the sectioning element 16 is fabricated fromnickel-titanium alloy that is shape set to move from the first,insertion configuration to the second, capture configuration uponreaching a transition temperature that is above room temperature butbelow body temperature. The sectioning element 16 fabricated fromnickel-titanium alloy thus may enter the eye at room temperature belowits transition temperature such that it will hold a constricted shape.As the sectioning element 16 is placed into the eye 1 and allowed towarm to body temperature, the nickel-titanium alloy may become warmerthan its transition temperature and begin to return to its predefinedsecond, capture configuration. This shape change may happen over aperiod of time that allows the surgeon to place the sectioning elementinto the capsular bag 6 and orient it while the shape changes such thatthe loop can define a sectioning plane through the lens. In someembodiments, the nickel-titanium alloy. Alternatively, any other numberof biocompatible materials may be considered such as stainless may bewarmed actively by the surgical device 40, in which case the transitiontemperature of the sectioning element 16 may be selected to be greaterthan room temperature but less than a temperature that would damage thetissue of the capsular bag 6 or other tissue of the eye 1. Other shapememory materials such as shape memory plastics may be utilized insteadof nickel-titanium alloy. Alternatively, any other number ofbiocompatible materials may be considered such as stainless steel,titanium, silicone, polyimide, PEBAX® polyether block amide, nylon,polycarbonate, or any other suitable material. Furthermore, multiplematerials joined end to end or in laminated layers or concentric tubesof material may be used.

Referring also to FIGS. 1 and 4, in the second, capture configuration,the sectioning element 16 is specifically shaped for lens capture.According to some embodiments, the second, capture configuration is apreset shape of the sectioning element 16, such as through the use ofelastic or superelastic materials to fabricate the sectioning element.

As seen most clearly in FIG. 4, in the second, capture configuration,the sectioning element 16 approximates an irregular loop that isgenerally shaped like the cross-section of a lens 8, and that is shapedand sized to surround the lens 8 within the capsular bag 6. As set forthabove, in some embodiments, the sectioning element 16 is fabricated froma length of round wire. The second, capture configuration of thesectioning element 16 has a merging point 22 where the first leg 18 andsecond leg 20 of the sectioning element 16 merge back together, forminga shape with a perimeter that approximates a closed loop. The “merging”refers to placing the first leg 18 and second leg 20 of the sectioningelement 16 into proximity with one another. The merging point 22 may belocated at or in proximity to the distal end of the shaft 12. In thesecond, capture configuration, the sectioning element includes a distalportion 28 that extends distal to the merging point 22 and a proximalportion 26 that extends proximally to the merging point 22. The mergingpoint 22 in this exemplary embodiment is at a point above the surface ofthe lens and within the circle defined by the capsulorhexis 10 at thetop of the capsular bag 6. In some embodiments, the proximal portion 26of the sectioning element 16 may include a tight radius bend 24 as shownin FIG. 1. The tight radius bend 24 bends the second leg 20 of thesectioning element 16 proximally such that the second leg 20 extendsproximally from the merging point 22. Alternatively, the sectioningelement 16 may take a different path to achieve this path transitionwithout such a sharp radius bend. For example, paths which are outsideof the normal plane of FIG. 1 such as curves or oscillations may beincorporated to reduce the overall bend radius of the proximal portion26 of the sectioning element 16. This may improve the ability of thesectioning element 16 to change shape into other smaller constrictedconfigurations as will be discussed below.

The first leg 18 and/or second leg 20 is pushed out of the lumen 14 ofthe shaft 12, while the other leg is fixed relative to the shaft, asdescribed above. Alternatively, both legs 18, 20 of the sectioningelement 16 are movable relative to the shaft 12 and configured to sliderelative to the lumen 14 of the shaft 12. Alternatively, the shaft 12may be the sliding component while the sectioning element 16 remainsstationary. As the leg or legs 18, 20 are pushed outward from the lumen14, the sectioning element 16 transitions to the second, captureconfiguration. As the sectioning element 16 transitions, the tightradius bend 24 allows the proximal section of the sectioning element toextend proximally from the distal end of the shaft 12, at a locationspaced from and to one side of the longitudinal centerline of the lumen12 in the direction toward the capsular bag 6. In this way, thesectioning element 16 is able to extend downward through thecapsulorhexis 10 and expand to a length within the capsular bag 6 thatis greater than the diameter of the capsulorhexis 10, as seen in FIG. 1.According to some embodiments, the tight radius bend 24 results in thesecond leg 20 having an angle of at least 120 degrees relative to thelongitudinal centerline of the shaft 12, and relative to the distaldirection, as seen in FIG. 1. Both the distal portion 28 and theproximal portion of the sectioning element 16 in the second, captureconfiguration are gently curved and generally approximate the size andshape of the lateral sides of the capsular bag 6, in order to enter thecapsular bag 6 without causing damage (e.g., such as a capsular tear orhole, over-stretching the capsular bag, or damaging the inner surface ofthe capsular bag tissue).

Referring also to FIG. 2, the shape of the sectioning element 16 in thesecond, capture configuration forms a plane that is generally flat orhorizontal with respect to the top lens surface, according to someembodiments. Referring back to FIGS. 1 and 3, with the correctorientation, the sectioning element 16 is held such that it opensthrough the capsulorhexis 10 into the capsular bag 6. As the sectioningelement 16 continues to expand, the plane formed by the sectioningelement 16 can be rotated so that the sectioning element traverses aspace between the capsular bag and the lens. The plane includes thelongitudinal axis of the lumen 14 of the shaft 12. Alternately, theshape of the sectioning element 16 in the second, capture configurationis a more three-dimensional shape that does not lie in a single plane.For example, the sectioning element 16 may oscillate in and out of aflat plane, or may be substantially curved out of a flat plane in onedirection or another. The rotation may be accomplished by manualrotation of the shaft 12 or surgical device 40 by the user, or may beaccomplished by integrated mechanisms within the surgical device 40, asdescribed in greater detail below. Referring also to FIG. 4, thesectioning element 16 has proceeded most of the way from the first,insertion configuration to the second, capture configuration, and hasbeen rotated partially relative to the lens 8. The sectioning element 16may be rotated such that the shape plane is primarily vertical or to anynumber of other angles. Mechanisms and methods for producing suchrotation are described in greater detail below. Additionally, multiplesectioning elements 16 may be used that rotate to a variety of angles.In other embodiments, the rotation does not occur until the sectioningelement 16 transitions to the second, capture configuration. Accordingto some embodiments, rotation begins while the sectioning element 16transitions to the second, capture configuration. For example, rotationmay begin once the open area 46 within the sectioning element 16 expandsto a size in which a 5-6 mm chord extends across the open area 46between two points on the proximal section 26 and the distal section 28.As another example, rotation may begin when the chord is longer than, orshorter than 5-6 mm.

The second, capture configuration of the sectioning element 16 may begenerally ovular in shape, referring to FIG. 1, with a width 7.0-15.0 mmand a height of 3.0-10.0 mm, according to some embodiments. According toother embodiments, the width of the sectioning element 16 may be4.0-20.0 mm with a height of 1.0-15.0 mm. In some embodiments the sizeof the second, capture configuration of the sectioning element 16 may beintentionally smaller than the size of the lens at certain areas oralong the entire profile. This may improve the ability of the sectioningelement 16 to remain close to the lens 8 and reduce interaction with thecapsular bag 6. For example, the second, capture configuration of thesectioning element 16 may be 12.0 mm wide and 4.0 mm high. This mayallow clearance between the sectioning element 16 and the lens 8 at thewidth of the oval while maintaining interference along the height of theoval which may reduce the likelihood of damaging the posterior surfaceof the capsular bag 6. That is, by configuring the second, captureconfiguration of the sectioning element 16 to engage a portion of lens8, rather than move to a position in which it encircles the thickestpart of the lens 8, the sectioning element 16 is sized smaller, andengages less of the capsular bag 6, than a configuration in which thesecond, capture configuration of the sectioning element 16 is able toencircle the thickest part of the lens 8. In other embodiments, thesecond, capture configuration of the sectioning element 16 is predefinedto have a generally specific clearance around the lens 8. According tosome embodiments, the second, capture configuration of the sectioningelement 16 has a different shape than generally oval.

The sectioning element 16 may have features or geometry which furtherprevents the element from damaging the capsular bag. For example, thesectioning element 16 is a round wire of sufficient diameter to reducethe likelihood of tearing or damaging the capsular bag 6, according tosome embodiments. The diameter of that round wire may be 0.004″-0.012,″but may also be any size that prevents excessive stress from beingplaced on the capsular bag 6, such as 0.001″-0.030″ diameter.Alternatively, the profile of the sectioning element 16 may be ovularwith a larger width or height, or may be a strap, to further distributethe force of the sectioning element 16 on the capsular bag 6 over alarger surface area, thereby reducing or eliminating areas of highpressure exerted on the capsular bag 6 by the sectioning element.

In some embodiments, portions of the outer surface of the sectioningelement 16 may be coated to improve certain aspects of the device. Forexample, as discussed in greater detail below, the sectioning element 16traverses a space between the capsular bag 6 and the lens 8. As thesectioning element 16 moves between these anatomical structures it maybe advantageous to have a more hydrophilic or hydrophobic surface so thesectioning element 16 rotates and moves more freely. In one embodiment,the sectioning element 16 may be coated with a hydrophobic material suchas a fluoropolymer; for example, PTFE. A coating can be added throughdip coating, plasma vapor deposition process, heat shrink sleeves, orany other suitable method. The coating can reduce the friction betweenthe sectioning element 16, and the lens 8 and/or capsular bag 6, toallow the sectioning element 16 to move more freely. Other methods ofreducing the friction may include using mechanical abrasion, plasmatreatments, or any other suitable method. Alternatively, the sectioningelement 16 may be coated with other materials such as activepharmaceutical agents which are configured to release into they duringthe procedure. For example, a steroid like triamcinolone may be added tothe surface of the sectioning element 16 such that during the procedureit releases into the eye. Any other number of coatings and drugs may becontemplated.

The sectioning element 16 may be constructed with any other suitablegeometries or materials. In an exemplary embodiment, the sectioningelement 16 is a round wire. The wire is configured to bluntly traverse aspace between the lens 8 and the capsular bag 6. The wire can havevarious sizes or diameters along the length of the sectioning element16. Alternatively, the sectioning element 16 may be any number of otherprofiles. For example, the sectioning element 16 could be a tube, aribbon, a strap, a wire with a hexagonal profile, or any other number ofsuitable shapes. In addition, the profile of the sectioning element 16could change along its length. For example, the sectioning element 16may include one or more padded areas along its profile where damage tothe capsular bag 4 is of particular concern. The padded areas mayinclude different materials, such as but not limited to soft elastomericmaterials like silicone that are bonded or coated onto appropriate areasof the sectioning element 16. The padded areas may distribute the forceover a larger area, and provide a softer and more atraumatic interfaceagainst the capsular bag 6. In other embodiments, the padded areas aregeometry profile changes of the sectioning element in certain areas. Forexample, areas which are flared out or broadened, even if comprised ofthe same material, distribute the force over a larger area.Additionally, the stiffness or flexibility of the sectioning element mayvary over the sectioning element 16 by changing the material thicknessor wire diameter in certain areas. Alternatively, sleeves or othermaterials may be added to the sectioning element 16 to increasestiffness locally in certain areas. In still other embodiments, thesectioning element 16 may have cuts or ribs along its length whichchange its flexibility or stiffness in certain areas.

In other embodiments, the shape of the sectioning element 16 in thesecond, capture configuration is not predetermined. Instead shape of thesectioning element 16 in the second, capture configuration is defined bythe material or geometric properties of the sectioning element 16,engaged with the lens 8. The sectioning element 16 may be sufficientlyflexible, elastic, soft, or blunt along its length, while maintainingsufficient stiffness to allow for rotation to engage the lens 8, suchthat minimal force is applied to the capsular bag 6 even when thesectioning element 16 is within the capsular bag 4 and fully opened. Inother embodiments, the sectioning element 16 may be a soft elastomersuch as silicone which may be sufficiently soft and large enough indiameter so that the sectioning element 16 does not place excessiveforce onto the capsular bag 6. In still other embodiments, thesectioning element 16 may be sufficiently blunt along certain portionsand edges such that the force applied to the capsular bag 6 isdistributed over a larger area and therefore the tearing pressure may bereduced. In still other embodiments, the sectioning element 16 may becomprised of a linkage of multiple elements, for example a chain-likestructure, allowing for flexible movement between the multiple elements.In still other embodiments, the sectioning element 16 may have slitsalong portions of its length which locally may increase its flexibility.For example, the sectioning element 16 may include a tube with cutoutsalong its length at areas where the capsular bag 6 may come in contactwith the sectioning element 16 such that these areas are more flexibleand therefore are less prone to putting excessive force onto thecapsular bag 6. In still other embodiments, portions of the sectioningelement 16 in the second, capture configuration are not predetermined inshape, while other portions of the sectioning element 16 arepredetermined in shape. For instance, a portion of the sectioningelement 16 anterior to the lens may be fabricated from a shape memoryround wire which is shape set to a predefined shape which aids inguiding the sectioning element 16 into the eye. For example, such aportion can include the tight radius bend 24 of the proximal portion 26.A portion of the sectioning element 16 posterior to the lens 8 may befabricated from a different, more-flexible material that more easilyconforms to the shape of the eye. In this way, the portion of thesectioning element 16 in the second, capture configuration that allowsfor insertion of the sectioning element through the capsulorhexis,including the tight radius bend, are anterior to the lens 8, and theportion of the sectioning element 16 in the second, captureconfiguration that contacts the capsular bag 6 is composed ofmore-flexible material even less likely to damage the capsular bag 6.

According to some embodiments, additional guide tubes or components mayalign or direct the path of the sectioning element 16 through thecapsulorhexis 10 and/or around the lens 8. For example, in embodimentswhere the sectioning element 16 in the second, capture configurationdoes not have a predefined shape, a guiding element may exist alongareas of the distal portion 28 or proximal portion 26 of the sectioningelement 16 to constrain it into a particular shape. A tube may extendfrom the merging point 22 in the direction of the distal portion 28, andthe tube may concentrically constrain the flexible sectioning element 16such that it more or less follows a desired path during insertion intothe capsular bag 6 and placement around the lens 4. The guiding tube maythen be retracted, leaving the flexible sectioning element 16 in placearound the lens 4.

In still other embodiments, the predefined shape of the sectioningelement 16 in the second, capture configuration may be created duringany part of the surgical procedure. For example, the surgeon may useimaging techniques to measure anatomical features of the eye such as thelens 8 or capsular bag 4. The surgeon may then use this information toor change a shape of the sectioning element. Alternatively, a piece ofequipment such as a forming die or an automated wire forming machinedmay be used in conjunction with the measured data to change the shape ofthe sectioning element 16 in the second, capture configuration. In oneembodiment, the surgeon uses an imaging modality such as OCT to performa measurement of the lens 8, and then this information is provided to anautomated wire forming station which creates a custom sectioning element16 for the patient. In still other embodiments, the surgeon may add orchange a shape of the sectioning element 16 while at least a portion ofthe sectioning element 16 is within the eye. For example, the surgeonmay begin to place the sectioning element 16 into the capsular bag 6 anddetermine that its shape may be improved. The surgeon may then insert aseparate tool such as forceps into the eye or use an integrated toolassociated with the shaft 12 to add or change a shape of the sectioningelement 16.

According to some embodiments, a fluid is introduced between thecapsular bag 6 after the capsulorhexis 10 is made, such that a space iscreated between the lens 8 and capsular bag 6 in at least some areas.This may be referred to as fluid dissection, hydro dissection or spacecreation. According to some embodiments, the fluid creates a space forthe sectioning element 16 in the second, capture configuration to berotated within the capsular bag 6 and surround the lens 8. In anexemplary embodiment, fluids such as viscoelastic hyalarunic acid orsaline may be injected since these materials are commonly used duringocular surgery, well-tolerated within the eye, and readily available.One or more other or additional fluids may be introduced, such as dyedfluids, pharmaceutical liquids like steroids, drug loaded fluids,bioabsorbable fluids, lubricants, hydro gels, microspheres, powderedsubstances, fluorescent contrast, liquid foams, or any other suitablefluid. Additionally, one or more gases additionally or instead may beintroduced, such as air, oxygen, argon, nitrogen, or the like.Alternatively, in other embodiments a fluid space may not be requiredbetween the lens 8 and the capsular bag 6, and the sectioning element 16may perform a mechanical dissection or blunt dissection of the lens 8and capsular bag 4, as it is rotated about the lens 8. Fluid dissectionand blunt dissection may be done in combination with one another orseparately. The fluid may be injected through a cannula or a needle intothe capsular bag 6 using a separate instrument. According to otherembodiments, provisions for fluid dissection may be incorporated intoelements of the surgical device 40, such as the sectioning element 16.For example, the sectioning element 16 may be fabricated as a flexibletube with a plurality of holes along its length that allow for thepassage of fluid therethrough. In such an embodiment, fluid may beintroduced into the lumen of the sectioning element 16 and then flow outof the plurality of holes. This may improve the ability of thesectioning element 16 to pass between the capsular bag 6 and the lens 8because the fluid may be introduced through the sectioning element 16continuously or at discrete points in time when dissection is needed. Instill other embodiments, the fluid injection may be incorporated inother aspects of the surgical device 40. For example, fluid may bedelivered via the lumen 14 of the shaft 12. Alternatively, a componentseparate from the shaft 12, such as a telescoping tube or other tube,may be connected to the shaft 12 to provide for fluid introduction. Insome embodiments, the fluid which is infused through a component of thedevice, such as the shaft 12 or the element 16, may be used for othersurgical purposes. For example, fluid may be infused through the shaft12 to maintain the chamber of the eye 1 without the need for a separatecannula or without the need for a viscoelastic substance. Irrigation andaspiration may be accomplished through a single component or throughmultiple separate components. For example, fluids such as saline may beirrigated into the eye through a lumen of an embodiment of thesectioning element 16, as described above, and aspirated through thelumen of the shaft 12. Other irrigation or aspiration techniques may beperformed, according to some embodiments.

Referring to FIG. 5, the sectioning element 16 has been fully extendedto the second, capture configuration, and has been rotated about thelongitudinal axis of the shaft 12 and/or otherwise rotated or moved toan orientation within the capsular bag 6 in which the sectioning element16 surrounds the lens 8 without exerting excessive force onto thecapsular bag 6. The sectioning element 16 is then used to cut the lens 8by tensioning one or both legs 18, 20 of the sectioning element 16, suchas by retracting one or both legs 18, 20 through the lumen 14 of theshaft 12. The sectioning element 16 may be moved in the opposite manneras set forth above for expanding the sectioning element 16 from thefirst to the second configuration, in order to compress and cut the lens8. As the sectioning element 16 is tensioned, it exerts an inward forceon the lens 8 and begins cutting and/or fragmenting it. Due to the forceapplied to the lens 8 across the small surface area of the thin diametersectioning element 16. The sectioning element 16 continues to betensioned until the lens 8 is partially or fully sectioned. In someembodiments the sectioning element 16 is tensioned until the lens 8 isfully sectioned. In other embodiments, tensioning of the sectioningelement 16 only partially fragments the lens 8, and the remainder of thelens 8 can be fragmented by repeating the use of the sectioning element,or with additional tools. Referring to FIG. 6, the fragmented lens 8 isshown within the capsular bag 6. The section plane is primarilyvertical, but it should be appreciated that any number of angles andorientations may exist for the cutting path of the sectioning element16. Referring to FIG. 7, the lens is shown with the capsular bagremoved.

In some embodiments, the surgical device 40 may incorporate multiplesectioning elements 16, as described below, to create multiple lensfragments at one time. For example, the multiple sectioning elements 16may form a mesh which is capable of cutting the lens 8 into a multitudeof fragments; the sectioning elements 16 may be at oblique or acuteangles relative to one another such that they form a criss-crosspattern. In other embodiments, the surgical device 40 may be usedsuccessively on the lens 8. For example, after a single section iscreated the lens 8 (or the sectioning element 16) can be rotated 90degrees such that the first section plane is now perpendicular to thedelivery device plane. The sectioning element 16 can then be reinsertedinto the capsular bag 6 as described above, and used to create a newsection across the two lens fragments which creates four fragments intotal. The process may be repeated for as many times as necessary tocreate any number of lens fragments of any desired size. The finaldesired size of the lens fragments may depend on method of extractionfrom the eye 1. In some embodiments, phacoemulsification additionallymay be used in the capsular bag 6 to remove the lens fragments. This maybe particularly useful in difficult or hard cataracts, where full lensfragmentation increases the surface area and decreases the size offragments that are to be emulsified by phacoemulsification. In otherembodiments, the lens fragments may be extracted as described below.

In some embodiments, the lens fragments may be pushed out of thecapsular bag 6 by introducing fluid into the capsular bag 6 under slightpressure. The fluid flow and/or pressure may move the lens fragmentsinto the anterior chamber of the eye 1, such that other tools andmethods for extracting the lens may be utilized. For example, forceps orgrasping tools may be used to grab the lens fragments and pull them outof the eye 1 through the corneal incision 4. In some embodiments, thesectioning element 16 may be used to snare the lens fragments and pullthem out of the eye 1. The sectioning element 16 may be returned to thesecond, capture configuration and placed around a lens fragment. Thesectioning element 16 may then be tensioned or otherwise closed untilthe lens 8 is held within of the sectioning element but the lensfragment is not cut. The lens fragment can then be pulled out of the eye1 with the sectioning element 16. To ensure that the lens 8 is not cutby the sectioning element 16, additional components may be used such aspads, straps, or strips with a larger surface area that grip the lensfragment rather than cutting it. These components can be extended fromthe shaft 12, or may be separate components that are inserted into theeye 1 through the incision 4 and attached to the sectioning element 16.

Referring to FIGS. 8-9, one embodiment of the surgical device 40includes two sectioning elements 16 extending from the distal end of ashaft 12, with a handle mechanism 42 attached to the proximal end of theshaft 12. Referring also to FIG. 15, two sectioning elements 16 areshown in the first, insertion configuration at the distal end of theshaft 12. The handle 42 has two sliders slidable longitudinally, whichare connected to the two sectioning elements 16 as described below. Thesliders in this initial configuration are in their retracted proximallocation. The shaft 12 and sectioning elements 16 in the first,insertion configuration are inserted through an incision 4 in the corneatoward a capsulorhexis 10, as described above. As used in this document,the term “handle” includes both handles configured for manual grippingand actuation by a surgeon, as well as a robotic handle that is coupledto a surgical robot and configured for robotic control and actuation.

Referring also to FIGS. 16-17, one embodiment of a handle 42 of thesurgical device 40 is shown in cutaway in a configuration correspondingto the first, insertion configuration of the sectioning elements 16. Aslider 44 is slidable along the top surface of the handle 42. A finger48 extends from the slider 44 into the handle 42 through a slot in thetop surface of the handle 42. The finger 48 is coupled to a helical cam50 or other cam structure, located proximal to the finger 48, that islongitudinally fixed to the finger 48 but that is free to rotate axiallyrelative to the finger 48. This may be accomplished mechanically throughan engagement pin, collar, or other suitable mechanism. A cam path 52 isdefined in the surface of the helical cam 50. The helical cam 50 isconfined within a chamber inside the handle 42 which allows the helicalcam 50 to slide longitudinally but not move substantially radially. Anose 56 extends distally from the finger 48 and is rotatable relative tothe finger 48. Advantageously the nose 56 is rotationally fixed to thehelical cam 50; in some embodiments, the nose 56 is simply the distalend of the helical cam 50. A retraction spring 58 is positioned betweenthe finger 48 and the front passage 60 out of the handle 42, acting topush the finger 48 toward the first, insertion configuration. Theproximal end of the retraction spring 58 may be centered on and engagethe nose 56. The proximal end of the first leg 18 of the sectioningelement 16 may be fixed to the nose 16 in any suitable manner, such asby wrapping around the nose, friction fitting, welding, soldering, or bypressure fitting. Alternately, the proximal end of the first leg 18 maybe fixed to the finger 48. A cam post 62 is defined in and/or fixedrelative to the handle 42, and engages the cam path 52. As the helicalcam 50 translates relative to a remainder of the handle 42, the cam post62 remains in the same place on the handle 42. Where two sectioningelements 16 are used, two such assemblies as described above (the slider44, finger 48, cam 50, nose 56, retraction spring 58 and connection tothe first leg 18 of the sectioning element 16) are utilized side-by-sidewithin the handle 42. Such assemblies may be identical to one another,may be lateral mirror-images of one another, or may vary from oneanother in other ways that allow substantially the same assembly tooperate two separate sectioning elements 16 in the manner describedbelow. The description of the motion of the sliders 44 a, 44 b and thesectioning elements 16 are the same for both sliders 44 and sectioningelements 16 unless otherwise noted, and the descriptions of the two areinterchangeable unless otherwise noted.

Referring to FIG. 10, one of the sectioning elements 16 is transitionedto the second, capture configuration by sliding the corresponding slider44 b distally. One leg 20 of the sectioning element 16 may be connectedto the shaft 12, handle 42, or other structure fixed relative to thehandle 42, and maintained in a fixed position while the first leg 18 isconfigured to translate and rotate with the moving elements within thehandle 42. As set forth above, the first leg 18 is attached to the nose56. Referring also to FIG. 18, as the slider 44 translates distally, thefinger 48 compresses the retraction spring 58, moves the nose 56distally, and pulls the helical cam 50 distally. The retraction spring58 is compressed and imparts a proximal force on the finger 48. If theuser releases the slider 44, the slider 44, finger 48, and mechanismstranslationally fixed to the finger 48 are pushed distally toward theinitial position of the slider 44. As the slider 44 advances distally,the helical cam 50 translates within the handle 42. The cam path 52 maybe substantially longitudinal during this first segment of motion of theslider 44, such that engagement between the cam path 52 and cam post 62does not cause rotation of the helical cam 50; therefore, the sectioningelement 16 remains in substantially the same rotational orientationrelative to the longitudinal axis of the shaft 12. As the slider 44advances distally, it pushes the first leg 18 of the sectioning elementdistally. As a result, the sectioning element 16 changes shape to thesecond, capture configuration, in the same manner as described abovewith regard to FIGS. 1-4.

Referring also to FIG. 11, the slider 44 may be further advanceddistally after the sectioning element 16 changes shape to the second,capture configuration. The cam path 52 engages the cam post 62 to rotatethe helical cam 50, as seen in FIGS. 18-20. The amount of distal motionof the slider 44 controls the amount of rotation of the helical cam 50.In this way, linear motion of the slider 4 is converted to rotary motionof the sectioning element 16. Because the helical cam 50 and the nose 56are rotationally fixed to one another, rotation of the helical cam 50causes rotation of the nose 56, and thus rotation of the sectioningelement 16 in the second, capture configuration. The sectioning element16 rotates, and the plane defined by the shape of the sectioning element16 correspondingly rotates. The sectioning element 16 is rotated fromits initial position, which may be substantially parallel to a planedefined by the edges of the capsulorhexis 10, to a position that isapproximately within 0-40 degrees from a vertical orientation. Duringthis rotation, the sectioning element 16 moves between the capsular bag6 and the lens 8, capturing the lens 8 in the open area 46 within theperimeter of the sectioning element 16. The sectioning element 16 maynot engage the capsular bag 6 and/or lens 8 substantially, or may beconfigured to engage either the lens 8 or the capsular bag 6.Alternately, the sectioning element 16 may cause a blunt dissectionbetween the capsular bag 6 and the lens 8.

Referring also to FIG. 20, the slider 44 is moved fully forward and therotation of the helical cam 50 and sectioning element 16 is complete.The sectioning element 16 surround the lens 8 within the capsular bag 6,and is configured to apply an inward cutting force relative to the lens8, in the manner described above with regard to FIGS. 4-5.

Referring also to FIGS. 12-13, a second sectioning element 16 then maybe deployed to a second, capture configuration, and rotated intoposition to surround the lens 8, in the same manner as described abovewith regard to FIGS. 9-11 and 16-20. Referring also to FIG. 14, bothsectioning elements 16 engage the lens 8, such that when the sectioningelements 16 are tensioned or otherwise closed, the sectioning elements16 will cut the lens 8 into three partially- or fully-separatefragments. Referring also to FIG. 21, the tensioning may be provided bysliding the sliders 44 proximally, thereby pulling the first leg 18 ofeach sectioning element 16 proximally and tensioning it. In someembodiments, the proximal force exerted on the finger 48 by theretraction spring 58 may be sufficiently large to cut the lens 8 withoutthe application of additional force by the user. In other embodiments,the user provides additional force that fragments the lens 8. This maybe necessary especially for hard or difficult cataracts. Each sectioningelement 16 engages the posterior surface of the lens 8 along a linespaced apart from the other sectioning element 16, and engages theanterior surface of the lens 8 along substantially the same line,according to some embodiments.

In FIG. 22, the slider 44 is moved proximally to return to the originalposition. The sectioning element 16 is rotated back to its originalplane of insertion, and then retracted toward the shaft 12. Referringalso to FIG. 15, the sectioning elements 16 may return substantially totheir initial configuration after sectioning the lens. The cam path 52of the helical cam 50 may be a closed loop as shown. Alternately, thecam path 52 may be a one-way path wherein the slider 44 must betranslated fully distally and then proximally to move it to the originalposition. In some embodiments, one-way latches or levers may beincorporated into the cam path 52 that prevent the helical cam 50 fromrotating or moving in certain directions, and may be included atdiscrete positions of the cam path 52 or along the entire cam path 52.

According to some embodiments, the sectioning elements 16 may beconfigured to move synchronously with the actuation of a single slider44, rather than each sectioning element 16 being coupled to a differentslider 44 a, 44 b as described above. If so, the sectioning elements 16may be configured to open and rotate at the same time. Alternately, therotation of the sectioning elements 16 may be staggered such that onesectioning element 16 opens first and rotates first before the othersectioning element 16. This may be accomplished by associating adifferent cam path 52 and cam post 62 with each sectioning element 16.In still other embodiments, two sliders 44 a, 44 b can be configuredsuch that a left slider 44 b will move both sliders 44 forward but theright slider 44 a will only move the right slider 44 a forward (or viceversa). The right slider 44 a may be configured to move both sliders 44a, 44 b backward and the left slider to move only the left slider 44 bbackward. Thus, the user may decide whether to move the sliders 44 a, 44b independently or synchronously.

According to some elements, the sectioning elements 16 are rotated inthe same direction. For example, the first sectioning element 16 opensand is then rotated into the capsular bag 6 in a clockwise direction.The second sectioning element then opens and is also rotated into thecapsular bag 6 in a clockwise direction. In this embodiment, the firstsectioning element 16 may rotate to an angle 10-40 degree beyond avertical plane, and the second sectioning element 16 may rotate to anangle 10-40 degree less than a vertical plane.

In still other embodiments, one or more additional or differentmechanisms may be used to deploy the sectioning elements 16. Forexample, a scroll wheel advancing mechanism or other rotating mechanismcould be used to deploy one or both sectioning elements 16. In someembodiments, the movement by the user is geared up or down to themovement of the sectioning element 16 such that moving a given amount ofthe user interface components moves the sectioning element 16 a greateror lesser amount through the use of gears, scaled pulleys or any othernumber of components. In some embodiments, certain parts of the surgicaldevice 40 may be mechanically powered through components such as motors,linear motors, pneumatics, hydraulics, magnets, or the like. Thesurgical device 40 may be incorporated as a part of one or more largerrobotic assemblies. For example, a robotic device which is configured toperform a cataract procedure may include an embodiment of the surgicaldevice 40. This may allow surgeons to perform parts of the describedmethod robotically. In some embodiments this may allow for alternatetechniques and methods such as approaching the capsular bag 4 throughthe sclera. According to some embodiments, at least inserting a shaft 12having a lumen 14 therethrough, through the corneal incision 4 towardthe capsulorhexis 10, and extending a sectioning element 16 out of thedistal end of the lumen 14, to cause the sectioning element 16 to bendaway from the axis of the shaft 12 through the capsulorhexis 10, expandto a size greater than the capsulorhexis 10, and capture at least a partof the lens 8, are performed under robotic control.

In some embodiments, the sectioning element 16 need not approximate aloop initially as it is placed into the capsular bag 6. For example, thesectioning element 16 may be a single piece of round wire that is fedinto the capsular bag 6 from the shaft 12, without doubling back onitself to form a loop. In such an embodiment, the distal tip of thesectioning element 16 is blunt to prevent puncture or damage to tissuewithin the eye 1. As the distal tip of the sectioning element 16 reachesthe wall of the capsular bag 6, it may be configured to bend with eithera predefined bend in its structure, or by tracking along the innersurface of the capsular bag 6. The sectioning element 16 may thentraverse a space between the lens 8 and the capsular bag 6 such that itgoes around a circumference of the lens 8. The sectioning element 16 maythen come back into the view of the user into the top portion of thecapsular bag 6 where the user can grab the sectioning element 16 withfeatures on the handle 42 such as grippers, or with a separate toolentirely. At this point, the sectioning element 16 surrounds the lens 8within the capsular bag 6 and approximates a loop. As one or both endsof the sectioning element 16 are tensioned and/or pulled, an inwardcutting force is applied to the lens 8 such that it is fragmented. Thesectioning element 16 of this embodiment may have a cross-section thatallows it to bend preferentially in certain directions more easily thanothers, such that the sectioning element 16 can bend as necessary totrack around the lens 8 but still follow a suitable path around the lens8 without going off track into tissue. This may include the use of apreferred bending moment cross-section like an “I” beam which bendspreferentially about certain planes. Alternatively, a tube with cutoutsto allow bending may be configured to bend in certain planes by placingthe cuts in this plane. Therefore, the sectioning element 16 may bendaround the lens 8, primarily in a distal-to-proximal manner. This mayimprove the ability of the sectioning element 16 to traverse a desiredgeneral path relative to capsular bag 6 and lens 8. In some embodiments,the sectioning element 16 may be entirely flexible such that its distaltip is unconstrained to travel in any predefined path. The distal tipmay be configured to include a magnet or electromagnetic components towhich a force can be applied to with an external electromagnetic field.An external device may then be used to control the location of thedistal tip of the sectioning element 16 such that it may be guidedaround the capsular bag 6 along a desired path. Any number of differentpaths or fragmentation planes may be contemplated with this embodiment.The surgical device 40 may incorporate various imaging modalities inorder to create a desired path for the distal tip of the sectioningelement 16 which does not damage the capsular bag 6.

In some embodiments, the sectioning element 16 may bifurcate intomultiple portions and/or multiple loops. For example, in the initialconfiguration, the sectioning element 16 may have a shape and profile asdescribed above. However, when transitioned to the second, captureconfiguration, the sectioning element 16 may bifurcate along its lengthinto two elements which may have the same or similar shapes, ordifferent shapes, each surrounding the lens 8 in whole or in part. Thismay allow the sectioning element 16 to cut the lens 8 into multiplefragments without using two separate sectioning elements 16.

In some embodiments, one or both of the sectioning elements 16 may beconfigured to apply one or more types of energy to aid in the bluntdissection or fragmentation of the lens 8. For example, one or both ofthe sectioning elements 16 may include one or more portions configuredto be heated through the use of electrically resistive wire that becomeshot as current is run through it. The increased temperature may improvethe separation of the capsular bag 6 and the lens 8 as well as aid insectioning the lens 8. Alternatively, any number of other modalities maybe used such as radio frequency ablation, electric cautery, ultrasonicvibratory energy, or the like.

In some embodiments, the handle 42 may incorporate fluid deliveryfeatures. For example, as described above, the sectioning element 16 orthe shaft 12 may allow the injection of fluids through the respectivecomponents. The handle 42 may include fluid passageways and paths thatconnect these components to external fluid sources through tubes,integrated connectors, or the like. Alternatively, the handle 42 mayinclude internal pressure injection systems that push fluid through theshaft 12. The fluid may be stored in a cylinder with a piston whereinthe piston is pressed forward by actuation components in the handle 42.For example, a separate slider or button may be connected to the pistonand arranged such that as the slider is moved by the user, the piston istranslated and expels a fluid from the cylinder into the injectionsystem. This may allow the user to control the delivery of fluid throughthe sectioning element 16, the shaft 12, or any other handle 42component at certain times during the procedure such as creating spacebetween the capsular bag 6 and the lens 8. Alternatively, the surgicaldevice 40 may be configured such that the fluid is injectedautomatically by the surgical device 40 during certain periods withinthe normal actuation of the device. For example, a spring may beconfigured to place a force on the piston such that as the helical cam50 moves through its path, the piston is configured to expel an amountof fluid.

Referring to FIG. 23, an alternate embodiment of sectioning elements 16is shown as a side view. Two sectioning elements 16 extend from thedistal end of the shaft 12. In this embodiment, the sectioning elements16 are arranged to loop around the lens 8 starting at the distal end 8 aof the lens 8, rather than around the sides of the lens 8 as describedabove. The sectioning elements 16 may be extended one at a time from thedistal end of the shaft 12 distally toward the distal end 8 a of thelens 8 and into the capsular bag. The sectioning element 16 mayapproximate a loop of wire which is configured to have a predefinedshape and curves to allow it go around the lens 8 without placingexcessive force on the capsular bag. This may include side-to-side bendsas wells as forward-and-back curves that form various three-dimensionalgeometries as the sectioning element 16 is extended from the deliverydevice. In order to enter the capsular bag and capture the lens 8, thesectioning elements 16 are configured to be shaped differently as theyexpand. Rather than being planar, these sectioning elements 16 arecurved downward from the shaft 12 in the second configuration, as seenin FIG. 23. Where multiple sectioning elements 16 are used, each may beconfigured to curve to a different degree than the other or others. Oneend of the sectioning element 16 may be extended while the other remainsrelatively fixed to the delivery device, or both ends may be extended atthe same time, as described above. As described above, the sectioningelement may have various profiles, materials, or flexibilities along itslength.

One of the sectioning elements 16 may be extended to traverse the spacebetween the capsular bag and the lens 8, and then may be moved downwardand proximally around the lens 8. A second sectioning element 16 may beextended as shown, and any number of other sectioning elements 16 may beused. In some embodiments, a forward extending sectioning element 16 maybe used in conjunction with a side extending sectioning element 16 asdescribed above, in order to create intersecting fragmentation planessuch that two sectioning elements 16 can slice the lens into 4 discretepieces. Furthermore, the fragmentation planes can be at any number ofangles to each other, and the sectioning elements 16 can extend aroundthe lens 8 from any number of directions such as a combination of theforward extending and side extending embodiments.

Referring to FIG. 24, another alternate embodiment is shown as a topview. In this embodiment, one of the sectioning elements 16 is attachedto a retention bag 70 along at least a portion of its exposed length.The retention bag 70 may be fabricated from a thin polymeric materialsuch as polyester, high density polyethylene, low density polyethylene,or any other suitable plastic. Alternatively, the retention bag may becomprised of a mesh like a small wire stainless steel braid, anickel-titanium alloy braid, or any other suitable material. Theretention bag 70 is connected to a portion of the sectioning element 16and forms a cavity whereby the sectioning element 16 can change betweenan open and constricted configuration, which opens and closes theretention bag 70. In one embodiment, the sectioning element 16 with theretention bag 70 can be put into a constricted shape and placed into theeye 1 of the patient through the incision 4. The retention bag 70 may beconcealed in the lumen 14 of the shaft 12 during insertion into the eye1 through the incision. Then, the sectioning element 16 can be placed atthe capsulorhexis 10 and inserted into the capsular bag 6 around thelens 8 as described above. In some embodiments, the retention bag 70 mayhave a predefined shape such as a profile of the lens 8 or a lensfragment. As the sectioning element 16 loops around the lens 8, theretention bag 70 follows the sectioning element 16, and the lens 8enters into the cavity formed by the retention bag 70. The sectioningelement 16 can be moved such that the entire lens 8 is scooped into theretention bag 70 all the way around the lens 8, according to someembodiments. The sectioning element 16 is then changed to a constrictedshape that closes the retention bag 70 and encapsulates the lens 8. Theretention bag 70 is then pulled out of the eye 1 through the incision 4.The lens 8 may fold and squeeze to pass through the corneal incisionlength 4 as it is removed. The retrieval bag 70 may be coated in anyappropriate manner to enhance the ability to remove it out of theincision 4, such as by reducing the coefficient of friction of theretrieval bag 70. In other embodiments, additional tools or componentsmay be used to fragment the lens 8 further, depending on the rigidity ofthe lens 8. For example, as shown in FIG. 24, multiple sectioningelements 16 may be inserted into the capsular bag to fragment the lens 8within the retention bag 70. These additional sectioning elements 16 maybe positioned at the same time as the retention bag 70 is positioned, ormay be introduced after the retention bag 70 has removed the lens 8 fromthe capsular bag but before the lens 8 has been removed from the eye 1.

In other embodiments, other fragmenting modalities may be used once thelens 8 is within the retention bag 70. For example, once the lens 8 hasbeen captured by the retention bag 70, ultrasonic energy orphacoemulsification may be used within the retention bag 70 to fragmentthe lens 8. This may include the use of telescoping probes into theretention bag 70 from the distal end of the shaft 12. Alternatively,mechanical instruments such as debriders, augers, or the like may beused to fragment the lens 8 sufficiently so that it may be pulled fromthe eye 1 through a narrow corneal incision 4.

In still other embodiments, the retention bag 70 described herein may beused as a retrieval device utilized after the lens 8 has beenfragmented, in order to remove the lens fragments from the eye 1. Forexample, the device shown in FIG. 1 may be used to cut the lens 8 intoany number of fragments. One or more of the fragments may besufficiently large such that they are difficult to retrieve through thecorneal incision 4 with normal instrumentation. A retention bag 70 maybe used to capture the lens fragments within the capsular bag orfloating in the anterior chamber, and pull them out of the cornealincision 4. Additionally, the retention bag 70 may have cutouts oropenings in it that allow the passage of fluid or small objects. Forexample, the retention bag 70 may be a mesh or a braid that allowsaqueous humor fluid or viscoelastic fluid to permeate through theopenings while still retaining the lens fragment.

Referring to FIGS. 25-29, another embodiment of a surgical device 80 isshown for the removal of lens fragments 8 f from the eye 1. The surgicaldevice 80 includes an outer rotating element 82 a and an inner rotatingelement 82 b. The elements 82 a, 82 b are arranged concentrically alonga central axis which may also define a longitudinal axis of the shaft12. Referring to FIG. 25, the surgical device 80 is initially in a firstconfiguration with the profile of the device small enough such that itcan be inserted through a standard corneal incision 4, as shown inFIG. 1. The outer rotating element 82 a and inner rotating element 82 bmay be tubes which have been cut along their length to produce straps 82circumferentially separated by windows 84. The outer rotating element 82a may have an outer diameter which is appropriately sized to be able tofit into the corneal incision, ideally the outer diameter being between0.015″ and 0.060″, although any outer diameter may be contemplateddepending on the incision length targeted. The inner rotating element 82b may have an outer diameter which is sized to fit concentrically withinthe inner diameter of the outer rotating element 82 a. The tubes of theouter rotating element 82 a and inner rotating element 82 b may be lasercut, machined, chemically etched, welded together, or manufactured withany suitable process in order to create the straps 82 and windows 84.The straps 82 may be sized to have any appropriate width that does notcut through the lens 8 f when a force is applied to constrict theelements 82 a, 82 b, as described below. The width of the straps 82 maybe between 0.004″ to 0.050″, although the straps 82 may have widthsoutside that range.

The outer rotating element 82 a and inner rotating element 82 b may beconstricted to a second, capture configuration such as pushing thedistal tip of the surgical device 80 forward with a separate componentlike a push rod, or by constraining the outer rotating element 82 a withan additional outer tube which sheaths the surgical device 80 duringinsertion into the eye. Alternatively, the surgical device 80 issufficiently flexible such that a constricting element is not requiredand the surgical device 80 flexes as it is inserted through the cornealincision 4. A distal tip 86 may be connected to the distal end of eachof the outer rotating element 82 a and inner rotating element 82 b, andprovides a smooth insertion into the corneal incision and blunt surfacefor contacting ocular structures. The distal tip 86 may be comprised ofa soft polymer such as PEBAX® polyether block amide, polyurethane,thermoplastic elastomer, or the like. Alternatively, the distal tip 86may be comprised of a hard material such a metal like stainless steel ortitanium, or biocompatible nonmetallic substance. Alternately, thedistal tip 86 may be sharp and allow the surgical device 80 to beinserted into the eye 1 without creating a previous incision 4, wherethe sharp distal tip 86 forms the incision. Where the outer rotatingelement 82 a and inner rotating element 82 b are composed ofsuperelastic material, the transition from the first configuration tothe second configuration may include a phase change of the material.

Advantageously, the straps 82 are configured to have a predefined openshape, such that once the surgical device 80 is within the anteriorchamber of the eye 1. It is opened such that the elements return totheir predefined shape. This may be accomplished using a shape memorymaterial such as nickel-titanium alloy in its superelastic state, whichis shaped to return to the open profile shown in FIG. 26 once aconstricting element is released. Alternatively, the nickel-titaniumalloy may return each strap 82 to an open shape once the device isinserted into the eye and allowed to heat to a body temperature which isabove the transition temperature of the nickel-titanium alloy.Alternately, heating elements may be connected to the surgical device 80to heat the surgical device 80 above an even higher transitiontemperature once the surgical device 80 is in a location where the openshape of the second configuration is desired. In other embodiments, theouter rotating element 82 a and inner rotating element 82 b may becomprised of any number of materials. For examples, elastic materialssuch as stainless steel, titanium, plastics, or the like may be usedwherein the deformation is below the strain limit for elastic recovery.Alternatively, portions or the entirety of the straps 82 may be composedof multiple materials which may be additionally different from portionsof the rotating elements 82 a, 82 b. For example, the straps 82 maybefabricated from nickel-titanium alloy and affixed to rotating elementsthat are comprised of stainless steel. In the embodiments shown in FIGS.25-29, each of the two rotating elements 82 a, 82 b includes two straps82. However, any other suitable number of straps 82 may be included aspart of each rotating element 82 a, 82 b, and any suitable number ofrotating elements 82 a, 82 b may be provided. For example, the devicemay include four rotating elements 82 a, 82 b stacked concentrically,with each containing only one strap 82. In this embodiment, the straps82 may be rotated such that they are all grouped together, furtherreducing the crossing profile of the device at the corneal incision 4.In some embodiments, the predefined shape of the straps 82 is theinitial configuration and the straps are flexed outward to the secondconfiguration.

Referring to FIG. 26, in the second configuration, the rotating elements82 a, 82 b define a plane, and enclose a central area that is open inorder to receive fragments of the lens may be looped by the device.Referring to FIG. 27, the surgical device 80 is moved to surround a lensfragment 8 f. Referring to FIG. 28, the inner rotating element 82 a andouter rotating element 82 b have been rotated relative to one anotherapproximately 90 degrees. The surgical device 80 is now in the third,rotated configuration. One or both of the rotating elements 82 a, 82 bmay be rotated to achieve the third configuration. For example, a tube88 attached to the proximal end of the outer rotating element 82 b,and/or a tube 90 attached to the proximal end of the inner rotatingelement 82 a, are rotated in order to rotated the rotating elements 82a, 82 b to the third configuration. In other embodiments, the rotatingelements 82 a, 82 b may be rotated to any other suitable angle relativeto one another. In the third configuration, the inner rotating element82 a and outer rotating element 82 b approximate a cage that surroundsthe lens fragment 8 f.

Referring to FIG. 29, the straps 82 are moved to constrict around thelens fragment 8 f In some embodiments, a constricting element such as anouter sheath or a push and pull rod may be used to constrict the straps82. In other embodiments, the mechanism or method to expand the strapsto the second configuration is reversed. For example, where the straps82 are superelastic, the straps 82 may be cooled or may be mechanicallyurged through a phase transition toward their initial shape. In otherembodiments, the rotating elements 82 a, 82 b constrict as they are ispulled through the corneal incision 4. The incision 4 squeezes andcompresses the straps 82 and the lens 8 such that the straps 82 and thelens 8 conform to the size of the incision 4 as they are pulled out.Additionally, other components and mechanisms may be incorporated toassist in removing the lens fragment 8 f from the eye 1. For example,compression springs, pneumatic mechanisms, motorized mechanisms, and thelike may be incorporated or used with the surgical device 80 to pull thelens fragments 8 f from the eye 1. In some embodiments, the straps 82may cut into the lens fragment 8 f or additionally fragment the lens.

In some embodiments, the straps 82 may incorporate or be attached toremoval bags as described above. A bag may exist between two or more 82straps on one or more of the rotating elements 82 a, 82 b. In the openconfiguration, the lens fragment 8 f is similarly able to be placedwithin the center area of the inner rotating element 82 a and outerrotating element 82 b. As the inner rotating element 82 a and outerrotating element 82 b are moved to the third configuration, the bag islikewise moved and captures the lens fragment.

In other embodiments, the device of FIGS. 25-29 may be constructed inany other suitable manner. For example, the rotating elements 82 a, 82 bmay not be connected at their distal end and instead may form an opencage. In some embodiments, the rotating elements 82 a, 82 b may not beconcentrically aligned or may be composed of non-tubular structures suchas wires or beams or the like.

Referring to FIG. 30, an alternate embodiment is shown. Rather than asingle shaft 12, a first delivery tube 12 a and second delivery tube 12b are provided. Each tube includes a lumen therethrough, and asectioning element 16 extends through the free end of each delivery tube12 a, 12 b to form a closed shape. The sectioning element 16 may havethe same characteristics as described above with regard to any of theembodiments. The second delivery tube 12 b is bent back proximally (tothe right as illustrated in FIG. 30), such that the proximal segment ofthe sectioning element 16 is able to rotate around a proximal end of thelens 8 in use. The free ends of the two delivery tubes 12 a, 12 b may bespaced apart from one another a distance that is less than the diameterof the capsulorhexis 10. Consequently, the delivery tubes 12 a, 12 b areable to deliver a flexible sectioning element 16 to the lens and providefor that sectioning element 16 to rotate relative to the lens 8 andsurround at least part of the lens, as described above. The use of asimple flexible sectioning element 16, rather than a superelasticsectioning element 16, may simplify construction of the device. One orboth of the delivery tubes 12 a, 12 b may be shaped in the same manneras at least part of a different embodiment of sectioning element 16shown in FIG. 1; for example, the second delivery tube 12 b may includethe tight radius bend 24 that is made by the sectioning element 16itself in the embodiment of FIG. 1. As described above, the sectioningelement 16 may be expandable from a less-open initial shape to amore-open capture shape. For example, as an initial shape, thesectioning element 16 may extend substantially linearly between the endsof the delivery tubes 12 a, 12 b, after which an additional portion ofthe sectioning element 16 may be pushed out of the end of one or bothdelivery tubes 12 a, 12 b to form the curved, capture shape of FIG. 30.The embodiment of FIG. 30 is operated substantially as described above.

In any of the embodiments above, vacuum suction may be incorporated intocertain elements of the device 40, 80 such as the lumen 14 of the shaft12, or the inner rotating element 82 a. The vacuum suction may be usedto aspirate small fragments of the lens or to hold a lens fragment inplace during movement.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theinvention should not be limited to the description of the embodimentscontained herein. Furthermore, although the various embodiments anddescription may specify certain anatomical locations, species, orsurgical procedures, it should be appreciated that these embodimentsapply to other locations, species, and surgical procedures.

1.-30. (canceled)
 31. An ophthalmic surgical device comprising: a handlecomprising an actuator; a hollow shaft extending distally of the handleand defining a longitudinal axis, the hollow shaft comprising a lumenand an outlet from the lumen; and a sectioning element operably coupledto the handle and extending through the lumen, the sectioning elementconfigured to transition between a collapsed, insertion configurationtowards a fully expanded, capture configuration, wherein the sectioningelement exits through the outlet during transition toward the fullyexpanded, capture configuration, wherein, when in the fully expanded,capture configuration, the sectioning element includes a first leg and asecond leg in proximity with one another within the outlet forming anapproximately closed loop having an open area, wherein the open areacomprises a distal portion positioned distal to the outlet and aproximal portion positioned proximal to the outlet that overlaps alateral side of the hollow shaft, and wherein tensioning the sectioningelement with the actuator transitions the sectioning element towards thecollapsed, insertion configuration and sections a lens within a capsularbag.
 32. The device of claim 31, wherein the sectioning element is awire having a first end region coupled to the actuator and a second endregion fixed relative to the handle, the open area formed between thefirst and second end regions of the wire.
 33. The device of claim 31,wherein the actuator tensions the sectioning element to reduce the sizeof the open area by proximally retracting at least one of the first andsecond legs.
 34. The device of claim 31, wherein the actuator tensionsthe sectioning element to reduce the size of the open area by proximallyretracting both of the first and second legs.
 35. The device of claim31, wherein the sectioning element comprises a Nitinol wire or a Nitinolstrap.
 36. The device of claim 31, wherein the sectioning element iscoated with a material to reduce friction.
 37. The device of claim 36,wherein the coating comprises a hydrophobic material.
 38. The device ofclaim 31, wherein a distal portion of the hollow shaft is dimensionedfor passage through a corneal incision.
 39. The device of claim 31,wherein the outlet in the hollow shaft is near a distal end of theshaft.
 40. The device of claim 31, wherein, with the sectioning elementin the fully expanded, capture configuration, a majority of thesectioning element positioned outside the hollow shaft is off-set from alongitudinal axis of the hollow shaft.
 41. The device of claim 31,wherein, with the sectioning element in the fully expanded, captureconfiguration, a majority of the open area of the sectioning element isoff-set to one side of a longitudinal axis of the hollow shaft.
 42. Thedevice of claim 31, wherein the second leg bends more than 120 degreesrelative to a longitudinal axis of the hollow shaft when the sectioningelement is in the fully expanded, capture configuration.
 43. The deviceof claim 31, wherein the actuator comprises at least one of a slider anda spring.
 44. The device of claim 31, wherein of the open area of thesectioning element comprises an unbiased, preset shape.
 45. The deviceof claim 44, wherein the sectioning element undergoes shape-changetoward the unbiased, preset shape during expansion of the sectioningelement from the collapsed, insertion configuration toward the fullyexpanded, capture configuration.
 46. The device of claim 44, wherein theunbiased, preset shape includes an approximately closed, non-planarloop.
 47. The device of claim 44, wherein the unbiased, preset shape issimilar in size and shape to a cross-sectional shape of the lens,wherein the cross-section is parallel to a transverse plane extendingfrom an anterior surface of the lens to a posterior surface of the lens.48. The device of claim 44 wherein the unbiased, preset shape comprisesa longer axis that corresponds in length to a major axis of thecross-section of the lens, and a shorter axis that corresponds in lengthto a minor axis of the cross-section of the lens.
 49. The device ofclaim 31, wherein a first inner perimeter of the sectioning elementdefining the open area is larger than a second perimeter of across-sectional portion of the lens when the sectioning element is inthe fully expanded, capture configuration.
 50. The device of claim 31,wherein the open area of the sectioning element when in the fullyexpanded, capture configuration has a diameter larger than a diameter ofa capsulorhexis in the capsular bag that is between 2 mm and 8 mm.